The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Ben Burnett - Stifel - Analyst
: Good morning. Thank you very much for taking the question. I appreciate the whole of this call. I had a question, you showed an interesting peak
expansion data with dose level 4b relative to dose level 3. I guess as you move forward with the three-day fludarabine lymphodepletion, what's
your expectation for what that means in terms of peak expansion and I guess do you anticipate that this will be compensated by the higher dose?
Alan List Thanks, Ben, and, yes, we are very excited about that data. We looked at other lymphodepletion regimens, including one with just three
days of fludarabine with the enhanced lymphodepletion Cytoxan dose which made no change at all. So, we fully expect that these levels that we're
seeing right now all relate to the improved product attributes alone.
Question: Ben Burnett - Stifel - Analyst
: Excellent.
Question: Soumit Roy - Jones Research - Analyst
: Good morning, everyone, and congratulations on the /robust data. Could you give us a little bit more detail on the two great heavy events that
we saw in the new dose cohort? Are they like much frailer patients? Did they had a higher disease burden? Anything that stands out would be
really appreciated.
Question: Soumit Roy - Jones Research - Analyst
: Perfect.
Question: Unidentified Participant - Barclays - Analyst
: Thank you for taking our questions. This is [Tom] for Gena. I have two questions. In the current setting of late line as you showed here, post allo
CAR T patient, how many patients should we think about would be eligible for PBCAR0191 and given the relatively short median survival or response
and what is your [real world] experience in screening in enrolling this population in your trial.
And then secondly, going to potential larger opportunity of the post second line auto CAR T patient as you outlined, how should we see about the
efficacy bar as the survival and response are like to improve with current options like in earlier line settings? I appreciate it.
Question: Andrea Tan - Goldman Sachs - Analyst
: Hi, everyone. Thanks for taking the question. Michael, maybe one question for you, just curious what dataset exactly you expect to have before
you engage with the FDA to discuss next steps. And then I have one follow-up.
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Question: Andrea Tan - Goldman Sachs - Analyst
: Got it. And then if I can ask a question on BCMA program. Just wondering if there's any details you can share on what that combo response looks
like for the dose level 2. Just curious how that compares to 29% ORR you saw with monotherapy.
Question: Unidentified Participant - Barclays - Analyst
: Hi, good morning. This is [Valentin] for Maury. Thanks for taking our question. You have noted optimized manufacturing as [gaping] dosing for
19B. Can you talk more about what is optimized? What gives you confidence talking about this for the next (inaudible)? Thank you.
Question: Patrick Trucchio - H.C. Wainwright - Analyst
: Thanks. Good morning and congrats on all the progress. Just a follow-up on Slide 26 so just regarding of potential approval for PBCAR19A. I'm
wondering if you can discuss more what the ideal registrational program can look like in terms of the number of patients enrolled or other elements
of the study design and specifically if there's any limitations to enrollment such a CD19 expression or other prior lines of treatment.
Question: Patrick Trucchio - H.C. Wainwright - Analyst
: Yes. That's helpful. Thank you.
Question: Raju Prasad - William Blair - Analyst
: Thanks for taking my question. I want to get a sense, maybe Dr. List, on the Blenrep for GSI data we saw at ASCO. Is there a reason why we should
think that using the GSI with the CAR T might have a different profile than with Blenrep or, I mean, how do you kind of think about that dataset in
the context of your study? Thanks.
Question: Raju Prasad - William Blair - Analyst
: Yes.
Question: Raju Prasad - William Blair - Analyst
: Good. Thanks. And ...
Question: Raju Prasad - William Blair - Analyst
: Yes. I guess one follow-up. You mentioned the CD19 management rates kind of varied which I think is pretty interesting. Were any of these patients
that were treated considers (inaudible) like negative relapsed or I assume none of them were in that category we hear about. Thanks.
Question: Justin Zelin - BTIG - Analyst
: Thanks for taking the question. So, we have heard some discussion at ASCO around cell expansion PK and its relationship to the durability response.
Can you speak with some of your translational data and what you consider to be meaningful durability to shape up for 191?
Question: Kelsey Goodwin - Guggenheim Securities - Analyst
: Thank you for taking my question. I know you said you haven't met with the FDA yet but I'm just wondering if maybe you could provide a bit of
color on how you think about a past to market imposed CAR T. I guess you anticipate you could enroll a line agnostic study and kind of be tied to
autologous label expansion into earlier line or do you anticipate kind of needing a trial per line of therapy. Thank you.
Question: Kelsey Goodwin - Guggenheim Securities - Analyst
: Got it. Okay. Thanks so much.
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